FDA Inspection 1010582 — Agilent Technologies, Inc.
The FDA completed an inspection of Agilent Technologies, Inc. on January 13, 2017 in Carpinteria, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Carpinteria, CA (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |